Safety and Clinical Performance of the Protecta ICD and CRT-D
Public ClinicalTrials.gov record NCT00982397. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
The PainFree SST Clinical Study: Clinical Study to Evaluate System Safety and Clinical Performance of the Protecta ICD + CRT-D and to Assess the Capacity of the Protecta Features to Reduce Inappropriate Shocks.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of the study is two-fold. In Phase I (Protecta Clinical Study), system performance will be evaluated. In Phase II (PainFree SST), the inappropriate shock-free rate at one year of subjects implanted with a Medtronic Protecta implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) will be evaluated.
Study identification
- NCT ID
- NCT00982397
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 2,770 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- Not listed
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 2009 (Type not available)
- Primary completion
- Sep 2013 (Actual)
- Completion
- Sep 2013 (Actual)
- Last update posted
- Nov 6, 2017
2009 – 2013
United States locations
- U.S. sites
- 29
- U.S. states
- 21
- U.S. cities
- 29
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Birmingham Heart Clinic PC | Birmingham | Alabama | 35235 | — |
| CardioVasular Associates of Mesa | Mesa | Arizona | 85206 | — |
| Mercy Hospital Fort Smith | Fort Smith | Arkansas | 72903 | — |
| LA Cardiology Associates | Los Angeles | California | 90017 | — |
| Cardiology Consultants of Napa Valley | Napa | California | 94558 | — |
| Hartford Hospital | Hartford | Connecticut | 06102 | — |
| University of Florida Health at Jacksonville | Jacksonville | Florida | 32209 | — |
| Arrhythmia Syncope Consultants LLC | Miami | Florida | 33133 | — |
| Indiana Heart Physicians | Indianapolis | Indiana | 46237 | — |
| Cardiovascular Research of Northwest Indiana | Munster | Indiana | 46321 | — |
| Iowa Heart Center | West Des Moines | Iowa | 50314 | — |
| Delmarva Heart Research Foundation | Salisbury | Maryland | 21804 | — |
| Essentia Institute of Rural Health | Duluth | Minnesota | 55805 | — |
| CentraCare Heart & Vascular Center | Saint Cloud | Minnesota | 56303 | — |
| Saint John's Medical Research Inc | Springfield | Missouri | 65804 | — |
| Saint Louis Heart & Vascular PC | St Louis | Missouri | 62040 | — |
| Cardiology PC | Syracuse | New York | 13210 | — |
| Pinehurst Medical Clinic | Pinehurst | North Carolina | 28374 | — |
| Ohio Heart and Vascular | Cincinnati | Ohio | 45219 | — |
| St. Vincent Mercy Medical Center | Toledo | Ohio | 43608 | — |
| Central Bucks Cardiology | Doylestown | Pennsylvania | 18901 | — |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| Pee Dee Cardiology | Florence | South Carolina | 29506 | — |
| Cardiology Consultants PA | Spartanburg | South Carolina | 29303 | — |
| Centennial Heart Cardiovascular Consultants LLC | Nashville | Tennessee | 37203 | — |
| Hall-Garcia Cardiology Associates | Houston | Texas | 77030 | — |
| Virginia Commonwealth University Health System | Richmond | Virginia | 23298 | — |
| Spokane Cardiology | Spokane | Washington | 99204 | — |
| Columbia St. Mary's Hospital | Milwaukee | Wisconsin | 53211 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 93 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00982397, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 6, 2017 · Synced Oct 27, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00982397 live on ClinicalTrials.gov.